Ionis Expands Partnership with Sobi for Olezarsen Commercialization Outside the U.S.

Ionis Pharmaceuticals, Inc. announced that it has entered into a license agreement under which Sobi receives exclusive rights in countries outside the U.S., Canada and China to commercialize olezarsen as a potential treatment for familial chylomicronemia syndrome (FCS) and severely elevated triglycerides. Ionis will continue to independently commercialize olezarsen in the U.S. Olezarsen was approved by the FDA in December 2024 under the tradename TRYNGOLZA as an adjunct to diet to reduce triglycerides in adults with FCS – the first and only treatment in the U.S. for this rare, debilitating genetic disease.

Olezarsen is currently under review by the European Medicines Agency (EMA) with a potential approval anticipated for the treatment of FCS this year. Sobi will be responsible for future regulatory submissions and commercialization in ex-U.S. geographies except Canada and China. Olezarsen was licensed to Theratechnologies for commercialization in Canada.

“We look forward to deepening our long-standing partnership with Sobi and our shared commitment to improving the lives of people living with conditions marked by severely elevated triglycerides,” said Brett P. Monia, Ph.D., chief executive officer, Ionis. “This agreement enables us to advance our goal of making olezarsen available to patients globally, while focusing our independent commercialization efforts in the U.S. With anticipated data from our robust sHTG Phase 3 program in 2025, we are enthusiastic about the potential for olezarsen to also address the significant medical need in this more prevalent patient population in addition to FCS.”

Sobi® (STO: SOBI) brings deep commercialization expertise for both rare and more prevalent conditions, with operations in more than 30 countries, and is committed to bringing olezarsen to as many global patients as possible. As Ionis’ current European commercialization partner for Waylivra® (volanesorsen), which is the only medicine approved for FCS in Europe, Sobi will leverage existing market expertise and distribution channels to enable an effective olezarsen launch in FCS and future potential expansion to a broader population with severely elevated triglycerides, assuming approval. Under the agreement, Ionis receives an upfront payment, additional payments based on achievement of milestones and a tiered royalty of up to mid-20% range on annual net sales.

“We are thrilled to continue our collaboration with Ionis and bring this potential new medicine to patients if approved,” said Guido Oelkers, chief executive officer, Sobi. “This will enable us to further leverage our combined strengths and to continue to deliver our commitment to provide innovative medicines that transform the lives of people with rare and debilitating diseases.”

In addition to FCS, Ionis is evaluating olezarsen for the treatment of severe hypertriglyceridemia (sHTG) in three Phase 3 clinical trials – CORE, CORE2 and ESSENCE. Data from ESSENCE are expected mid-2025 and data from CORE and CORE2 are expected in the second half of 2025.